A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population
- To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population.
- To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.
- To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.
- To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.
Device: SaeboFlex Dynamic Hand Orthosis
Procedure: Saebo F.T.M. Arm Training Program
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Pilot Study Investigating the Feasibility of Using a Functional Tone Management (F.T.M.) Arm Training Program With the SaeboFlex Dynamic Hand Orthosis on an Inpatient Population|
- Hand grip strength (measured using dynamometry) [ Time Frame: At admission and at discharge ]
- Length of Stay (days) [ Time Frame: The duration of the subject's inpatient hospital stay. ]
- Stroke Impact Scale Score [ Time Frame: At admission and at discharge ]
- Action Research Arm Test Score [ Time Frame: At admission and at discharge ]
- Ashworth Assessment (Upper Extremity) Scores [ Time Frame: At admission and at discharge ]
- Fugl-Meyer Assessment (Upper Extremity) Scores [ Time Frame: At admission and at discharge ]
- Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist) [ Time Frame: At admission and at discharge ]
- Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range) [ Time Frame: At admission and at discharge ]
|Study Start Date:||August 2005|
|Study Completion Date:||May 2006|
Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the past two years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury population. During that time, two factors, other than the severity of the initial injury, were identified as having a significant affect on the outcomes achieved in treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the proper treatment dosage and treatment protocol for the application of the F.T.M. Program to the inpatient post stroke rehabilitation population. Additionally, information on functional outcome measures will be collected and compared to a matched control group that undergoes the standard therapeutic protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489580
|United States, New Jersey|
|Kessler Institute for Rehabilitation|
|East Orange, New Jersey, United States, 07018|
|Principal Investigator:||Elie P Elovic, M.D.||Kessler Medical Rehabilitation Research & Education Center|